UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050829 |
|---|---|
| Receipt number | R000052335 |
| Scientific Title | Prevention of pneumonia in stroke patients |
| Date of disclosure of the study information | 2023/04/13 |
| Last modified on | 2023/10/31 12:04:57 |
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Basic information
Public title
An exploratory study of prevention of pneumonia by positional adjustment in acute stroke patients at Hospital A
Acronym
Prevention of pneumonia by positional adjustment in acute stroke patients
Scientific Title
Prevention of pneumonia in stroke patients
Scientific Title:Acronym
Prevention of pneumonia
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Neurology | Rehabilitation medicine | Nursing |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The actual incidence of pneumonia in our hospital has been suggested in a previous study that National Institutes of Health Stroke Scale scores of 12 or higher may be a high-risk population for developing pneumonia, and the time to develop pneumonia after stroke was within 7days in 75% of patients . In light of these results, it is essential to investigate whether nursing care can prevent the development of pneumonia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of pneumonia from day of admission to day 8 of hospitalization
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
The method of positioning is to perform two sets of forward leaning side lying position for at least 30 minutes and no more than 180 minutes on each side per day for 7 days after admission.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Stroke patients, excluding subarachnoid hemorrhage, who are admitted to our neurology department and have a NIHSS score of 12 or higher at the time of admission
Key exclusion criteria
Patients who are deemed by the attending physician to be unable to participate in the study, such as those who have undergone craniotomy and have had their skull removed.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Satomi |
| Middle name | |
| Last name | Miyanosita |
Organization
Saga University Hospital
Division name
nursing department
Zip code
8498501
Address
5-1-1 Nabeshima, Saga City, Saga Prefecture
TEL
0952316511
f9774@cc.saga-u.ac.jp
Public contact
Name of contact person
| 1st name | Yumi |
| Middle name | |
| Last name | Konishi |
Organization
nursing department
Division name
Brain Nerve Center
Zip code
8498501
Address
5-1-1 Nabeshima, Saga City, Saga Prefecture
TEL
0952316511
Homepage URL
f9774@cc.saga-u.ac.jp
Sponsor or person
Institute
National Institute of Biomedical Research and Innovation (NIBIO)
Institute
Department
Personal name
Funding Source
Organization
National Institute of Biomedical Research and Innovation (NIBIO)
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Center, Saga University Hospital
Address
5-1-1 Nabeshima, Saga City, Saga Prefecture
Tel
0952343400
f9774@cc.saga-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 04 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2023 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 04 | Month | 13 | Day |
Last modified on
| 2023 | Year | 10 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000052335
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
